A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus
This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study was that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.
Participants were randomized on Day 1 to the following arms:
At Week 12, participants who met the up-titration criteria were re-randomized to the following arms for Weeks 12 to 54:
The placebo arm continued receiving placebo from Week 12 to Week 54.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Sacramento, California 95821, United States
Hollywood, Florida 33021, United States
Brussels, Bruxelles-Capitale, Region de 1200, Belgium
Montreal, Quebec H1T 2M4, Canada
Santo Domingo, Nacional 10101, Dominican Republic
Guatemala City, 01014, Guatemala
Pécs, Baranya 7623, Hungary
Békéscsaba, Bekescsaba 5600, Hungary
Miskolc, Borsod-Abauj Zemplen county 3526, Hungary
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Forbach, Pamplemousses District 21014, Mauritius
Guadalajara, Jalisco 44150, Mexico
Madero, Tamaulipas 89440, Mexico
Marikina City, National Capital Region 1810, Philippines
Wierzchosławice, Lesser Poland Voivodeship 33-122, Poland
Moscow, Moscow 117036, Russia
Rostov-on-Don, Rostov Oblast 344012, Russia
Samara, Samara Oblast 443079, Russia
Saint Petersburg, Sankt-Peterburg 194100, Russia
Voronezh, Voronezskaja Oblast 394024, Russia
Mecca, Al Bahah Region 24211, Saudi Arabia
Jeddah, Makkah Al Mukarramah 21423, Saudi Arabia
Al Ahsa, Riyadh Region 31982, Saudi Arabia
Riyadh, Riyadh Region 11564, Saudi Arabia
Ankara, 06800, Turkey (Türkiye)
Chernivtsi, Chernivetska Oblast 58002, Ukraine
Dnipro, Dnipropetrovsk Oblast 49100, Ukraine
Kharkiv, Kharkiv Oblast 61153, Ukraine
Kyiv, Kyivska Oblast 01021, Ukraine
Kyiv, Kyivska Oblast 04114, Ukraine
Vinnytsia, Vinnytsia Oblast 21010, Ukraine